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Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
“The following presentation should not be regarded as an endorsement of a particular product/drug/technique by the speaker. The presentation topics were assigned to the speakers by the scientific committee of the KCA, to be presented/interpreted as part of a comprehensive scientific debate. Therefore, this presentation should not be viewed/interpreted in isolation, and should be considered in context with the other presentations in the same session. "
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Nivolumab as a second-line therapy for metastatic RCC
Saby George, MD, FACP
Associate Professor of Medicine and OncologyGenitourinary Oncology Program
Roswell Park Cancer Institute11/05/2016
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Disclosures
I have consulted/ worked in a scientific advisory role for
Astellas
Bayer
Bristol-Myers Squibb
Novartis
Onclive
Pfizer
Sanofi
Xcenda
Exelixis
I have received research funding from
Agensys
Acceleron
Bayer
Bristol-Myers Squibb
Novartis
Pfizer
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Previously Treated RCC: What's Best?
Phase III Checkmate-025 data
Efficacy
Safety
QOL improvement
TBP and examples of long term benefit
McDermott data (ASCO 2016)
Comparative and contrast
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comSharma et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comSharma et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comSharma et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comSharma et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
11/2011 8/2016
Patient XX
This 67 year old lady was on Nivolumab (CA209010) trial and got treated for 2 years. Then she discontinued
Nivolumab nearly 3 years ago and maintained the complete response.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
11/2011 1/2012
Patient YY
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
1/2012 3/2015
This 52 year old man went on to have a CR and is maintaining CR nearly 5 years after initiating Nivolumab.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Checkmate-025 Treatment Beyond Progression
Escudier et al . Checkmate 025 TBP. ASCO 2016.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Tumor Burden Changes With Nivolumab According to
Best Overall Response
Escudier et al . Checkmate 025 TBP. ASCO 2016.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Overall Survival with TBP vs NTBP
Escudier et al . Checkmate 025 TBP. ASCO 2016.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Long term/ durable benefit from Nivolumab
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Comparative efficacy/ safety data
Nivolumab
(Checkmate 025)
Phase III
Cabozantinib
(Meteor)
PHASE III
Lenvatinib +
Everolimus
PHASE II
Axitinib
(Axis)
PHASE III
ORR (%) 25 17 30 19
QOL
AE grade 3+4 (%) 19 68 71 NA (54% required
dose interruptions )
Discontinuation
rates due to TRAE
(%)
8 12 24 4
OS (Months) 25 21.4 25.5 20.1 (NS)
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Summary
• The Checkmate-025 trial demonstrated the efficacy of Nivolumab in
Treatment refractory RCC population
• The safety profile has been established by phase I/ II trials and it has been
confirmed by the larger trial-025
• The fact that the QOL improves after starting Nivolumab attests to the
fact that in addition to the safety and efficacy, patients feels better when
they are treated with Nivolumab
• McDermott data demonstrates long term durable benefit leading to OS
advantage from Nivolumab in a vast majority of patients
• Moreover, after being on a TKI for a long time in the first-line setting, it is
better to give them a break from this class of drugs
• Nivolumab is the best second line therapy for mRCC after prior TKI use.
Fifteenth International Kidney Cancer Symposium
November 4-5, 2016
Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com
Acknowledgements
• Mentors:
• Brian Rini, MD and Ronald Bukowski, MD
• Colleagues:
• David McDermott, MD
• Pam Sharma, MD
• Robert Motzer, MD
• BMS (slide provision)
• Patients and the coordinators
• KCA